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About POGO's Federal Contractor Misconduct Database (FCMD)

The government awards contracts to companies with histories of misconduct such as contract fraud and environmental, ethics, and labor violations. In the absence of a centralized federal database listing instances of misconduct, the Project On Government Oversight (POGO) is providing such data. We believe that it will lead to improved contracting decisions and public access to information about how the government spends hundreds of billions of taxpayer money each year on goods and services. Report an instance of misconduct »

Instances of Misconduct

A U.S. Food and Drug Administration (FDA) inspection of a Sanofi-Aventis pharmaceutical facility in April and May 2010 found the company failed to comply with the postmarketing reporting requirements of the Federal Food, Drug, and Cosmetic Act. The violations included inadequate written procedures for the surveillance, receipt, evaluation, and reporting of adverse events of products including the Lovenox blood thinner, the Multaq heart drug and the Allegra D allergy pill; failure to submit serious and unexpected adverse drug experience (ADE) reports within 15 calendar days to FDA; and failure to include all postmarketing studies in the Annual Report to FDA.... more»

A U.S. Food and Drug Administration (FDA) inspection of Sanofi Aventis Deutschland GmbH’s Frankfurt, Germany facility in September 2010 identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals. The violations included failing to establish or follow appropriate written procedures designed to prevent microbiological contamination of the Apidra insulin treatment; failing to establish separate or defined areas or such other control systems as necessary to prevent contamination or mix-ups during aseptic processing; and failing to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education training, and experience to enable that person to perform the assigned functions.... more»

The U.S. Federal Trade Commission (FTC) notified Sanofi-Aventis U.S. LLC, Watson Pharmaceuticals, Inc., and Synthon Holding B.V., alleging that the companies violated the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) by failing to inform antitrust authorities about drug patent agreements involving Sanofi’s insomnia drug Ambien CR. The MMA requires companies to file such agreements with the FTC and U.S. Department of Justice within 10 business days of their execution, or else face a civil penalty of $11,000 per day. The FTC decided not to recommend an enforcement action because the violation did not appear to have harmed consumers or benefitted the companies, and the failure to file did not appear to have been a deliberate effort to evade the requirements of the MMA.... more»

Aventis Pharmaceutical Inc., a subsidiary of Sanofi-Aventis U.S. LLC, agreed to pay the United States $95.5 million to settle allegations that it violated the False Claims Act by misreporting drug prices in order to reduce its Medicaid Drug Rebate obligations. The government alleged that between 1995 and 2000, Aventis and its corporate predecessors knowingly misreported best prices for its steroid-based, anti-inflammatory nasal sprays Azmacort, Nasacort and Nasacort AQ. The Medicaid Drug Rebate Statute requires drug manufacturers to report to Medicaid the lowest, or "best," price that it charges commercial customers and pay quarterly rebates to the states based on those reported prices. It was alleged that, in order to avoid triggering a new best price that would obligate it to pay millions of dollars in additional rebates to Medicaid, Aventis entered into "private label" agreements with Kaiser Permanente that repackaged Aventis’s drugs under a new label.... more»

Aventis Pharmaceuticals Inc. agreed to pay $190,433,326 "to resolve allegations that the company caused false claims to be filed with Medicare and other federal health programs as a result of the company's alleged fraudulent pricing and marketing of drugs." The case involved the pricing between 1997 and 2004 of Anzemet, a treatment given to cancer patients after chemotherapy. The government alleged Aventis engaged in a scheme to set fraudulent and inflated prices for Anzemet knowing that federal health care programs established reimbursement rates based on those prices. The settlement will be split between the federal government and the governments of several states and the District of Columbia.... more»

The European Union fined eight pharmaceutical companies, including Aventis SA (formerly Rhône-Poulenc), a total of 855.2 million euros (approximately $752 million) for colluding to fix the price of vitamins between 1989 and 1999. The eight companies had been under investigation since 1999 for colluding to eliminate fair competition for vitamins and overcharging consumers in the European market. Aventis was exempted from fines for its involvement in cartels accused of rigging the market for vitamins A and E because of its cooperation with investigators, but was fined 5.04 million euros (approximately $4 million) for participating in the vitamin D3 cartel.... more»

A nationwide class-action lawsuit was filed on behalf of all individuals who paid for prescriptions of the heart medication Cardizem CD, manufactured by Aventis, and/or its generic versions between 1998 and 2003. The lawsuit alleged Aventis and Andrx, maker of the generic version of Cardizem CD, conspired to keep the generic version off the market, causing consumers and third party payers to overpay for the drug. Aventis and Andrx agreed to pay $80 million, in addition to a separate $110 million settlement reached between the companies and drug wholesalers involving the same allegations.... more»